SC0245 and Irinotecan in Treating Patients With Relapsed Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Sponsor
Biocity Biopharmaceutics Co., Ltd.
Study ID
NCT05731518
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SC0245 — DRUG
    SC0245 Quaque Die(QD) administered with a 3-day on and 4-day off schedule in Day 1 Day8 and Day 15 of each cycle. One cycle is consisted of 28 days.
  • Irinotecan — DRUG
    Irinotecan 80mg/m\^2 via IV administered for every 4 weeks (fixed dosing) in Day 1 Day8 and Day 15 of each cycle. One cycle is consisted of 28 days.

Study Details

This study is a single arm, multi-center, open label phase Ib/II study of SC0245 and Irinotecan combination therapy in subjects with extensive-stage small cell lung cancer (ES-SCLC) as a second therapy. This study will have three parts, phase 1 dose escalation (Part 1), phase 1 dose expansion (Part 2), and phase 2 combination therapy (Part 3).

Key Dates

Start date
Feb 23, 2023
Status verified
Feb 2023
Primary completion
Sep 30, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
67 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SC0245 and irinotecan combination
    SC0245 and irinotecan combination are administered one cycle that is consisted of 28 days until disease progression or death or loss of follow-up or withdrawal.

Primary Outcome Measure

Part 1 (phase 1 dose escalation):Maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) of SC0245 and irinotecan [ Time Frame: Up to 28 days ]

Central Contacts

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